Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients (DC-Ova)

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This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide.

Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse.

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

The following conditions must be met before a patient may be enrolled in the study.

Patients age 18 years of age and older.

Disease Criteria. Patients will be eligible:

If no clinical evidence of disease is present after diagnosis with stage III or

IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.or primary peritoneal carcinoma.

Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be ≥50% or within the normal range of the institution. A cardiology clearance will be required for LV ejection fraction <50%.

Hepatic: SGOT within 2x normal range and total bilirubin ≤ 2.0 mg/dL.

Renal: Serum creatinine ≤2.0 mg/dL

Adequate performance status > 80% (Karnofsky) or ECOG 0-2

Written informed consent conforming to institutional guidelines.

Life expectancy > 6 months and absence of co-existing medical problems which would preclude participation in the judgment of the principal investigator.

Exclusion Criteria:

Any one of the following conditions eliminates a patient from participating in this protocol.

Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.

Use of immunosuppressive drugs within 4 weeks prior to study entry or anticipated use of immunosuppressive agents.

Patients with tumors of low malignant potential (borderline tumors) will not be eligible.

Seropositivity for HIV, HTLV-1, or HTLV-2.

Prior Influenza vaccination with the current vaccine will exclude patient from receiving protocol-specified influenza vaccine but will not exclude participation with the other aspects of the protocol. Each year's vaccine supply generally becomes available in October. Patients with a history of serious hypersensitivity to eggs, previous influenza vaccine or its components, will not receive influenza vaccine, but may continue to participate in other aspects of the protocol. Patients with a history of serious hypersensitivity to the Prevnar vaccine, its components, or diptheria toxoid will not receive the Prevnar vaccine, but may continue to participate in other aspects of the protocol.